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NCT03187223 · OUTCOME

Complete Remission Rate

Bendamustine and Melphalan in Myeloma · Source last updated 2025-01-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
60 days

What was measured

Number of Patient achieving complete remissions (CR1) at 60 days after ASCT

Analysis population: Response rates were assessed according to the International Myeloma Working Group (IMWG). Bone marrow (BM) was assessed by cytomorphology, histopathology with immunohistochemistry, and immunophenotyping by multiparameter flow cytometry (MFC) for detection of measurable residual disease (MRD). MRD negativity was defined by less than 10-5 aberrant plasma cells after measuring at least 1000000 nucleated cells.

Groups in this outcome

Arm A (Mel)

Melphalan 100mg/m2/day iv days -2 and -1 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.

Arm B (BenMel)

Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0. Bendamustine: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A (Mel)60
Arm B (BenMel)60

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A (Mel)31Not reportedNot reportedNot reportedNot reported
Arm B (BenMel)42Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        31
      2. group Id
        OG001
        value
        42
denoms
  1. counts
    1. group Id
      OG000
      value
      60
    2. group Id
      OG001
      value
      60
    units
    Participants
description
Number of Patient achieving complete remissions (CR1) at 60 days after ASCT
groups
  1. description
    Melphalan 100mg/m2/day iv days -2 and -1 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.
    id
    OG000
    title
    Arm A (Mel)
  2. description
    Melphalan 100mg/m2/day iv days -2 and -1 Bendamustine 200mg/m2/day iv days -4 and -3 Melphalan: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0. Bendamustine: High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.
    id
    OG001
    title
    Arm B (BenMel)
param Type
COUNT_OF_PARTICIPANTS
population Description
Response rates were assessed according to the International Myeloma Working Group (IMWG). Bone marrow (BM) was assessed by cytomorphology, histopathology with immunohistochemistry, and immunophenotyping by multiparameter flow cytometry (MFC) for detection of measurable residual disease (MRD). MRD negativity was defined by less than 10-5 aberrant plasma cells after measuring at least 1000000 nucleated cells.
reporting Status
POSTED
time Frame
60 days
title
Complete Remission Rate
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice